Abstract Background Hemolysis detection for whole blood samples is getting increased attention due to its unrecognized impact on results especially when testing is performed at the point-of-care (POC). GEM Premier 7000 with iQM3 (GEM 7000) is a new blood gas system that automatically detects hemolysis in samples using an integrated hemolysis detection module. Here, we investigate potential cross-interference from bilirubin and lipids on hemolysis measurement. Methods GEM 7000 utilizes 570 nm as the primary wavelength for hemoglobin and 610 nm as the secondary wavelength to monitor for sample turbidity. For evaluating cross-interference, native or hemolysate spiked whole blood samples were run in duplicate before and after the addition of bilirubin or lipid interferences. Two levels of lipids (150, 250 mg/dL) were added to three levels of native or hemolysate spiked whole blood (20, 240 – 260, 430 – 510 mg/dL plasma free hemoglobin pfHb). Two levels of bilirubin (9.9 and 24.7 mg/dL) were added to two levels of native or hemolysate spiked whole blood (20, 96 – 106 mg/dL pfHb). GEM 7000 provides results in hemolysis categories, therefore the agreement of the result category in the presence and absence of interferent was determined. Additionally, pfHb values were extracted to estimate the observed bias with and without interference. pfHb was also taken into consideration when evaluating bias at very low or very high concentrations. Results The presence of lipids or bilirubin showed no cross-interference on the GEM 7000 H index. Difference charts using the extracted pfHb values showed a mean bias of 3.6 and 5.6 mg/dL for all samples at the tested lipid and bilirubin levels, respectively. For hemolyzed samples (pfHb 20), the presence of lipids and bilirubin resulted in a mean bias of 10%. Conclusion These results demonstrate that the GEM 7000 hemolysis detection is not impacted by the presence of high levels of lipids and bilirubin that tend to co-exist, especially in neonatal samples. By providing integrated hemolysis detection in whole blood measurement, the GEM 7000 system can provide quality and confidence in the interpretation of the results at POC.
Balasubramanian et al. (Wed,) studied this question.